Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06492018

Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population

This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario infanta Leonor

Madrid, 28031, Spain

Location contact

Jorge Valencia, MD, PhD

CONTACT

Pablo Ryan, MD, PhD

CONTACT

[email protected]

About this study

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). The virus can cause both acute and chronic disease, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Globally, around 50 million people per year are living with HCV, resulting in 244,000 deaths. The WHO estimates that only 36% of individuals chronically infected with HCV are diagnosed, and the WHO HCV targets include increasing the diagnoses to 90% by 2030. WHO guidelines, published in 2021, strongly recommend offering self-testing for HCV as an additional approach to HCV testing services.

The Panbio™ HCV Self Test, is a lateral flow test, designed for the qualitative detection of antibodies specific to HCV in finger-stick whole blood. The test is designed to be used by lay users and uses a sample volume of 10 µL. The professional use version test (Bioline™ HCV Test) is commercially available and has previously been clinically validated by the manufacturer, demonstrating a sensitivity of 99.3-100% and a specificity of 98.1-100%.

Evaluation of the test performance when used by professional users has been conducted, and evaluation of lay user sensitivity and specificity based on lay user populations outside the EU is being conducted. This study will demonstrate the test performance and usability of the test when used in a European lay user population. The study will be conducted at one recruiting hospital in Spain.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is aged 18 or over
  • Participant agrees to all aspects of the study and is able and willing to provide informed consent / assent with parental consent.

Exclusion criteria

  • Participant has already participated in this study on a previous occasion.
  • Participant is deemed unfit for the study by the Investigator.
  • Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.
  • Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience
  • Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.
  • Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.
  • Participant is unwilling or unable to provide informed consent.

Treatment and study plan

Panbio™ HCV Self Test

Diagnostic Test

Rapid diagnostic test (self-test and professional) plus laboratory reference tests

Other names: Fingerstick HIV testing (optional), Laboratory reference testing for HCV (immunoassays and PCR, CE marked)

Primary outcomes

  1. Lay user / professional user test result concordance

    Time frame: 5 months

    To assess the concordance between the Panbio™ HCV Self Test, as performed by lay users based on self-collected finger-stick samples, and the Panbio™ HCV Self Test performed by a trained health care worker, who also will collect the finger-stick sample required for the test and perform the test.

  2. Lay user / laboratory test result concordance

    Time frame: 5 months

    To establish clinical performance (concordance with the reference test) for the Panbio™ HCV Self Test, as performed by lay users using finger-stick whole blood samples, when compared to reference testing using venous plasma samples.

Secondary outcomes

  1. Labelling comprehension evaluation

    Time frame: 5 months

    To evaluate user experience and lay user participants' understanding of the test through a questionnaire. The participant questionnaire includes questions which are intended to evaluate the lay user's understanding of the Quick Reference Guide / Instructions for Use. Most questions have a Yes / No answer option, with free text possible. Some questions require a free text answer.

  2. Results interpretation evaluation

    Time frame: 5 months

    To evaluate the lay users' understanding of static test results (mock devices).

  3. Usability evaluation - lay user experience

    Time frame: 5 months

    To assess the usability of the Panbio™ HCV Self Test, as performed by lay users, based on a participant questionnaire evaluation by the lay user participant. The participant questionnaire includes questions to assess the lay users' experience when performing the test. Most questions have a Yes / No answer option, with free text possible. Some questions require a free text answer.

  4. Usability evaluation - Self-test observer records

    Time frame: 5 months

    To assess the usability of the Panbio™ HCV Self Test, as performed by lay users based on a questionnaire evaluation by the study staff observer. In the observer questionnaire, particular attention will be paid to compliance regarding factors considered critical for the test, such as reading the IFU/ QRG and applying the correct test volume.

    The observer questionnaire is not reporting scores on a scale, but is recording observations regarding how the users complete each step. For each step, a question is asked whether the user conducted a certain procedure, and a Yes / No answer is requested, with Monitor Notes when applicable.

  5. Lay user / professional user results interpretation concordance

    Time frame: 5 months

    To assess the concordance between the self-test results (obtained by the self-tester) when interpreted by the lay user and by the observer.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla S Forssten, PhD

CONTACT

[email protected]

+447792902244

Jocelyn Farge, MSc, MBA

CONTACT

[email protected]

+33666483563

Sponsors and collaborators

Lead sponsor

Abbott Rapid Dx

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.